Apparatuses for the implantation of medical devices and methods of use thereof

ABSTRACT

A medical device may include a shaft extending between a proximal end and a distal end. The shaft may include a lumen therein. The medical device may include a handle coupled to the proximal end of the shaft and may include a mode selector. The mode selector may be adapted to transition between a first mode and a second mode of the medical device. The medical device may further include a compressed fluid source. In the first mode, the compressed fluid source may be fluidly coupled with the shaft so as to impart a negative pressure in at least a portion of the lumen. In the second mode, the compressed fluid source may be fluidly coupled with the shaft so as to impart a positive pressure in the at least a portion of the lumen.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. Application No.17/733,814, filed Apr. 29, 2022, which is a continuation of U.S.application Ser. No. 17/128,606, filed Dec. 21, 2020, which is adivisional of U.S. application Ser. No. 16/092,878, filed on Oct. 11,2018, now issued as U.S. Pat. No. 10,905,466 which is a U.S. nationalstage filing under 35 U.S.C. § 371 of International Application No.PCT/US2017/027807, filed on Apr. 14, 2017, which claims the benefit ofpriority under 35 U.S.C. § 119 of U.S. Provisional Patent ApplicationNo. 62/323,160, filed on Apr. 15, 2016, and U.S. Provisional PatentApplication No. 62/393,970, filed on Sep. 13, 2016, the entirety of eachof which is herein incorporated by reference.

TECHNICAL FIELD

Aspects of the present disclosure generally relate to medical devicesand procedures. In particular, some aspects relate to minimally invasiveapparatuses for the implantation of medical devices and methods relatedthereto.

BACKGROUND

Breast implants are among the largest implantable medical devices in thehuman body today. Due to their volume, mass, and surface area,implantation of these devices can require larger incisions for insertionand proper positioning. Current techniques often create extensivesurgical wounds that can stimulate a complex and dynamic healingprocess, e.g., to replace devitalized and missing cellular structuresand tissue layers. For example, many current techniques require a largeincision, manipulated by retractors and tissue-spreaders to expand andhold open the incision site for the physical manipulation of the implantinto the tissue pocket. These techniques can increase the size of thescar, the probability of damage to the implant, and/or the possibilityof infection; can require insertion of drainage tubes to evacuate serousfluids from surrounding tissue and capillary damage; and/or canaccelerate inflammatory responses that impact the healing process. Inaddition, keloids and hypertrophic scars represent an overgrowth ofdense fibrous tissue that usually develops after healing of a skininjury. It is recognized that the larger the incision, the greaterpotential incidence for keloid and hypertrophic scarring. Certainpatients are also more susceptible to, and are at higher risk of, keloidformation.

The systems, devices, and methods of the current disclosure may rectifyor lessen some or all of the challenges described above, and/or mayaddress other needs not met by prior technology.

SUMMARY

Aspects of the present disclosure relate to, among other things,minimally invasive devices for the implantation of medical devices andmethods related thereto. Each of the aspects disclosed herein mayinclude one or more of the features described in connection with any ofthe other disclosed aspects.

In one aspect, a medical device may include a shaft extending between aproximal end and a distal end. The shaft may include a lumen therein. Ahandle may be coupled to the proximal end of the shaft and may include amode selector. The mode selector may be adapted to transition between afirst mode and a second mode of the medical device. The medical devicemay further include a compressed fluid source. In the first mode, thecompressed fluid source may be fluidly coupled with the shaft so as toimpart a negative pressure in at least a portion of the lumen. In thesecond mode, the compressed fluid source may be fluidly coupled with theshaft so as to impart a positive pressure in the at least a portion ofthe lumen.

Examples of the medical device may further include any one or more ofthe following features. A nozzle may be coupled to the distal end of theshaft. The nozzle may be tapered towards a distal opening. The distalopening of the nozzle may be ovular. The nozzle may be removably coupledto the distal end of the shaft. The compressed gas source may include acartridge coupled to, and detachable from, the handle. A pump may befluidly coupled to the compressed gas source. The compressed gas sourcemay include a tubing assembly. The medical device may include a valvemechanism.

In another aspect, a medical device may include a shaft extendingbetween a proximal end and a distal end. The shaft may include a lumentherein. A handle may be coupled to the shaft. The handle may comprise amode selector and an actuator. The mode selector may be adapted totransition between a first mode or a second mode of the medical device.A valve mechanism may be in communication with the mode selector and theactuator. A compressed fluid source may be coupled to the shaft. In thefirst mode, the compressed fluid source may impart a negative pressurecontrolled by the actuator in at least a portion of the lumen. In thesecond mode, the compressed fluid source may impart a positive pressurecontrolled by the actuator in the at least a portion of the lumen.

Examples of the medical device may further include any one or more ofthe following features. The compressed gas source may include acartridge coupled to the handle and may be removable from the medicaldevice via mating features. A pump may be fluidly coupled to thecompressed gas source and housed within the handle. The compressed gassource may include a tubing assembly adapted for attachment to acentralized gas supply. A nozzle may be removably attached to the distalend of the shaft. The nozzle may be tapered and include a distalopening.

In a further aspect, a method may include selecting a first mode of amedical device via a mode selector coupled to a handle of the medicaldevice. The medical device may further include a shaft including alumen. The method also may include applying vacuum pressure to the lumenvia an actuator coupled to the handle to draw an implant into the lumen.Further, the method may include selecting a second mode of the medicaldevice via the mode selector applying expulsion pressure to the lumenvia the actuator to expel the implant from the shaft.

Examples of the method may further include any one or more of thefollowing features. The method may include coupling a nozzle to a distalend of the shaft after applying the vacuum pressure and before applyingthe expulsion pressure. The medical device may include or may be coupledto a source of compressed gas for applying the vacuum pressure and theexpulsion pressure. The implant may be a breast implant, and drawing theimplant into the lumen may compress the breast implant. The method mayinclude coupling a distal end of the shaft to a sterile packagecontaining the implant before applying the vacuum pressure.

In a further aspect, a medical device may include a shaft extendingbetween a proximal end and a distal end. The shaft may include a lumentherein. A handle may be coupled to the proximal end of the shaft. Avalve assembly may be disposed within the handle. A tubing assembly mayhave a first end coupled to the handle and a second end adapted forattachment to a centralized gas supply.

Examples of the medical device may further include any one or more ofthe following features. A nozzle may be removably attached to the distalend of the shaft. The nozzle may be tapered and include a distalopening. The distal opening of the nozzle may be ovular.

Both the foregoing general description and the following detaileddescription are exemplary and explanatory only and are not restrictiveof the features, as claimed. As used herein, the terms “comprises,”“comprising,” or other variations thereof, are intended to cover anon-exclusive inclusion such that a process, method, article, orapparatus that comprises a list of elements does not include only thoseelements, but may include other elements not expressly listed orinherent to such a process, method, article, or apparatus. Additionally,the term “exemplary” is used herein in the sense of “example,” ratherthan “ideal.” As used herein, the terms “about,” “substantially,” and“approximately,” indicate a range of values within +/−5% of a statedvalue.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate exemplary aspects that, togetherwith the written description, serve to explain the principles of thisdisclosure.

FIG. 1 illustrates a variety of incision locations for implantation of abreast implant;

FIG. 2 illustrates an exemplary introducer device, according to aspectsof the present disclosure;

FIG. 3 illustrates an exemplary chamber of the introducer device of FIG.2 , according to aspects of the present disclosure;

FIGS. 4A and 4B illustrate additional exemplary chambers of theintroducer device of FIG. 2 , according to further aspects of thepresent disclosure;

FIGS. 5A and 5B illustrate further exemplary chambers of the introducerdevice of FIG. 2 , according to aspects of the present disclosure;

FIG. 6 illustrates an exemplary chamber having a sheath, according toaspects of the present disclosure;

FIGS. 7A and 7B illustrate an additional exemplary introducer device,according to aspects of the present disclosure;

FIGS. 8A and 8B depict the formation of a subcutaneous tunnel during aprocedure;

FIGS. 9A and 9B illustrate a system for forming a tunnel and deliveringan implant during a procedure, according to aspects of the presentdisclosure;

FIGS. 10A-10C illustrate another exemplary system for forming a tunneland delivering an implant during a procedure, according to aspects ofthe present disclosure;

FIGS. 11 and 12 illustrate an exemplary introducer device coupled with acompressed gas source, according to aspects of the present disclosure;

FIG. 13 illustrates another exemplary introducer device, according toaspects of the present disclosure;

FIGS. 14 and 15 illustrate fluid flow through an exemplary introducerdevice, according to aspects of the present disclosure;

FIGS. 16A and 16B illustrate another introducer device, according toaspects of the present disclosure;

FIGS. 17A and 17B illustrate a further introducer device, according toaspects of the present disclosure;

FIGS. 18 and 19 illustrate a sterile package of an exemplary implant;and

FIG. 20 illustrates an exemplary introducer device coupled to thesterile package of FIGS. 18 and 19 .

DETAILED DESCRIPTION

Examples of the present disclosure relate to systems, devices, andmethods for treating internal areas of a patient's body. Such systems ordevices may include an introducer device and an implant for introductioninto the body (e.g., into a breast pocket) of a patient. Reference willnow be made in detail to examples of the present disclosure describedabove and illustrated in the accompanying drawings. Wherever possible,the same reference numbers will be used throughout the drawings to referto the same or like parts.

The terms “proximal” and “distal” are used herein to refer to therelative and directional positions of the components of an exemplaryintroducer device. When used herein, “proximal” refers to a positioncloser to the exterior of the body of the patient or closer to anoperator and/or medical professional using introducer device. Incontrast, “distal” refers to a position further away from the operatorand/or medical professional using the introducer device, or closer tothe interior of the body of the patient.

The introducer devices described herein may be used to deliver any oneor more implants via any one or more of various minimally invasiveprocedures. In at least one example, the implant may be a breast implantwith elastic properties, e.g., super visco-elastic and/or highly elasticproperties. According to some aspects of the present disclosure, theimplant may comprise silicone filling gel (e.g., the breast implant maybe pre-filled with the silicone gel prior to implantation). The siliconefilling gel may have a penetration value ranging from 1.0-6.0. Thepenetration value is a factor that measures the firmness of a colloid,such as a silicone gel. The implant may comprise a shell (e.g., an outercasing) with biocompatible surfaces. In some aspects, the shell may havea combination of low roughness, high kurtosis (e.g., referring to thedistribution of peak heights and valley depths of the surface), andskewness of the surface. Any of the features of implants disclosed in U.S. Provisional Application No. 62/334,667, filed on May 11, 2016, and/orU.S. Provisional Application No. 62/410,121, filed on Oct. 19, 2016, areincorporated by reference herein in their entireties. As such, the shellmay have friction surface properties to facilitate smooth delivery andimplantation of the implant within the body of the patient. Examples ofsuitable breast implants may include, but are not limited to, Motivaimplants produced by Establishment Labs, such as, e.g., Motiva ImplantMatrix® SilkSurface™ and VelvetSurface™. While references to breastimplants are used throughout the remainder of this disclosure, thedisclosure is not so limited. Rather, the systems, devices, and methodsdisclosed herein may be used to deliver any one or more of breast,gluteal, calf, and/or other such implants into the body of the patient.

FIG. 1 illustrates a variety of incision locations for implantation of abreast implant. As shown, a breast implant may be introduced into abreast pocket (e.g., breast pocket 130, FIG. 8A) of a patient through anunder-the-breast or inframammary incision 2; a transaxillar orthrough-the-armpit incision 4; the periareolar or areolar incision 6; orthe transumbilical or through-the-belly-button incision 8. As shown, thevarious incision types may necessitate an opening of varying size and/ordimension. For example, the size of an inframammary incision 2 istypically larger than a transumbilical incision 8. The selection of anincision type (e.g., insertion site) and size may depend on a number ofvariables and patient/physician preferences such as, e.g., the sizeand/or shape of the implant, the physical characteristics of the patient(e.g., the amount of adipose tissue, degree of skin elasticity, and/orphysical condition of the patient), the patient's age, and/or thepatient's lifestyle.

Disclosed herein are a variety of instruments, devices (e.g., introducerdevices), systems, and methods to allow for the introduction of anelastomeric implant (such as, e.g., breast, gluteal, and/or calfimplants) in a minimally-invasive manner. FIG. 2 illustrates anexemplary introducer device 10 for delivery of an implant 12. Implant 12may comprise a high strength shell 14 with visco-elastic and lowfriction surface properties as discussed above. Implant 12 is moldable,pliant, compressible, or otherwise movable between a compressed,elongated, insertion configuration (as shown in e.g., FIGS. 2, 3, and5A) and a deployed or expanded configuration (as shown in, e.g., FIG.5B). A maximum diameter or dimension of implant 12 in the insertionconfiguration may be limited by a size of a lumen of a shaft 16 withinwhich implant 12 may be received. For example, in some examples, theinner diameter of the shaft may range from about 1-3 inches or fromabout 1.5-2.5 inches, e.g., about 1, 1.5, 2, 2.5, or 3 inches. As shown,the insertion configuration is a low profile or compressedconfiguration. Implant 12 may be positioned within introducer device 10in the insertion configuration and, following delivery out of introducerdevice 10 and into the body of the patient, implant 12 may expand,decompress, or otherwise assume the deployed configuration.

As shown in FIG. 2 , introducer device 10 includes a shaft 16 having alumen (not shown in the orientation of FIG. 2 ) therein. As mentionedabove, the inner diameter of the shaft 16 may range from about 1-3inches or from about 1.5-2.5 inches, e.g., about 1, 1.5, 2, 2.5, or 3inches. Further, for example, the outer diameter of the shaft 16 mayrange from about 1.05 inches to about 3.5 inches, e.g., about 1.05,1.55, 2.05, 2.55, or 3.05 inches. The length of the shaft 16 may rangefrom about 7 inches to about 12 inches, or from about 8 inches to about10 inches, e.g., a length of about 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11,11.5, or 12 inches. The dimensions of the shaft 16 may be selected orcorrespond to the volume of the implant 12. In at least one example, anintroducer device 10 having a 9-inch shaft may be used for a 300 ccimplant. Further, for example, a 1-inch shaft may be used for a 200 ccimplant, or a shaft between about 2-3 inches may be used for an implantof 500 cc or more. Any one or more portions of shaft 16, such as aninner surface of shaft 16 may include a lubricious (e.g., hydrophilic)coating to reduce the coefficient of friction between one or moreportions (e.g., the inner surface) of introducer device 10 and one ormore portions (e.g., shell 14) of implant 12. For example, prior toimplantation, implant 12 may be housed, received, or otherwise at leastpartially disposed within the lumen of shaft 16 of introducer device 10.The hydrophilic coating may reduce the coefficient of friction betweenshell 14 and the interior surface of shaft 16, enabling a smoothtransition between the insertion configuration and the deployedconfiguration, e.g., upon exit of implant 12 from introducer device 10.

Optionally, introducer device 10 may include a unique device identifier(UDI) with information useful for identifying introducer device 10. Forexample, the UDI may include a micro-transponder for post-implantationdevice recognition and traceability. In some aspects, themicro-transponder includes one or more sensors with the ability tomeasure temperature, change in electrical impedance, and/or pressure,e.g., to be used as a control signal to alert or diagnose shell 14rupture, infection of the patient's tissue, and/or signs of aninflammatory response of the patient's tissue by monitoring thesurrounding tissue temperature. Such a UDI/sensor may be placed in anysuitable position on or within introducer device 10, including, forexample, the inner surface of the introducer device 10 proximate and/orin contact with implant 12.

In some aspects, implant 12 may be pre-loaded or inserted into a chamber(or introducer sheath) 18 to facilitate the sterile loading of implant12 into shaft 16 and/or manipulate (e.g., compress, elongate, etc.)implant 12 toward the insertion configuration. Additionally, chamber 18(or chamber 22 of FIGS. 5A and 5B, described below) may protect implant12 during an implantation procedure. For example, introducer device 10may provide for an implant profile diameter that correlates to a smallincision in the range of about 1.0 cm to less than about 3.0 cm, or inthe range of about 2.0 cm to 2.5 cm. As such, chamber 18 may compressthe diameter of implant 12 equal to or smaller than the incision size.Chamber 18 may have any appropriate shape or arrangement to urge implant12 toward and/or maintain implant 12 in the insertion configurationwhile inside introducer device 10. As shown in FIGS. 2 and 3 , forexample, chamber 18 is a foldable or rollable, highly-flexible, thinpolymeric sheathing material that may be rolled or wrapped at leastpartially around implant 12 to thereby compress and/or elongate implant12 into the insertion configuration. Once wrapped around implant 12,chamber 18 may have a U-shaped cross-section as shown in FIG. 3 .Alternatively, once wrapped around implant 12, chamber 18 may have aC-shaped shaped cross-section, as shown in FIG. 4A. While each of FIGS.3 and 4A illustrate a gap or space between terminating edges 18A and 18Bof chamber 18, the disclosure is not so limited. In some arrangements,edges 18A and 18B may abut or overlap one another such that the chamber18 envelopes or surrounds the entire circumferential surface of implant12 in the insertion configuration. Optionally, chamber 18 may include ahinge 20 between portions of chamber 18, e.g., providing a generallyclam-shell (e.g., two-part, halved) arrangement. Hinge 20 may be locatedalong an internal or external surface of chamber 18. In some examples,hinge 20 may be a living hinge (e.g., a hinge formed of a thinneddimension relative to a remainder of chamber 18 so as to enable bendingalong the thinned portion). In any such manner, hinge 20 is positionedso as to minimize exposure of hinge 20 to implant 12 and/or surroundingpatient tissue, thereby preventing inadvertent trauma, injury, orabrasion of implant 12 and/or patient tissue.

In some arrangements, the chamber may comprise a shape memory material.For example, chamber 18 may be replaced with chamber 22 illustrated inFIGS. 5A and 5B. Chamber 22 includes one or more shape-memory materials.Exemplary shape-memory materials include, but are not limited to, shapememory polymers and metal alloys such as nickel-titanium (Nitinol,including nickel-titanium wire structures) that may havethermal-recovery properties. For example, chamber 22 includes aplurality of struts 24 monolithically formed or woven, braided, orotherwise joined together in an expandable structure. In such anarrangement, chamber 22 may be tubular and allow for the constrictionand/or containment of implant 12 within the tubular structure of chamber22 that incorporates the shape-memory material(s), at a low transitiontemperature (e.g., lower than ambient room temperature), therebyreducing the insertion diameter of implant 12 to less than or equal tothe incision size, as shown in FIG. 5A. Upon warming (e.g., by exposureto body temperature or a warm saline flush), the shape-memory materialmay expand to a preset or predetermined shape and diameter, as shown inFIG. 5B. Expansion of chamber 22 according to this arrangement may allowfor the expansion of implant 12 housed therein, and facilitate removalof the chamber 22.

Returning to FIG. 2 , at least a portion (e.g., a proximal end) ofchamber 18 (or chamber 22) is received within the lumen of shaft 16 andsecured thereto via a connector 26. For example, connector 26 mayinclude a compression ring that tightens circumferentially aroundchamber 18 (or chamber 22) and around a distal end of shaft 16 to securechamber 18 (or chamber 22) to shaft 16. In such a manner, connector 26prevents movement of chamber 18 (or chamber 22) relative to shaft 16.

Once implant 12 is received within shaft 16, e.g., via chamber 18 orchamber 22, a medical professional may grasp a handle 30 of introducerdevice 10. Handle 30 may be a squeeze-type or compression handle, e.g.,operating in a manner similar to a caulking gun, in which a first arm 32is rotatable about a pivot 34 and movable toward a second arm 36. Pivot34, in turn, is coupled to a plunger rod 38 via any appropriate gearand/or linkage system (not shown) such that rotational movement of pivot34 is transferred into linear movement of plunger rod 38. Such a gearingand/or linkage system may include a ratchet 40 to enable controlled,gentle, and incremental advancement of implant 12 via a plunger head(not shown) coupled to a distal end of plunger rod 38. The plunger headmay have a dimension (e.g., diameter) corresponding or similar to adimension (e.g., diameter) of implant 12 in the insertion configuration.As such, upon squeezing first arm 32 toward second arm 36, plunger rod38 is advanced toward chamber 18 (or chamber 22) and the plunger headforces, pushes, advances, or otherwise moves implant 12 distally ofchamber 18 (or chamber 22) (as shown in FIG. 2 ) and into the breastpocket of a patient (or other site of implantation suitable for the typeof implant), while chamber 18 (or chamber 22) remains securely connectedto shaft 16 via connector 26.

In another arrangement, however, plunger rod 38 is stationary so as toprevent implant 12 from “backing out” of chamber 18, e.g., during animplantation procedure. For example, the plunger head of plunger rod 38may be positioned at a proximal end of chamber 18 so as to limitproximal movement of implant 12 (e.g., the plunger head may abut,contact, or otherwise inhibit movement of implant 12 proximally). Insuch cases, introducer device 10 may include a mechanism for retractingchamber 18 in order to release implant 12 from chamber 18. In at leastone example, squeezing first arm 32 toward second arm 36 of handle 30may pull chamber 18 proximally while plunger rod 38 remains stationaryto prevent proximal movement of implant with chamber 18.

FIG. 6 illustrates another example of retraction of chamber 18, whereina frangible sheath 42 is positioned about chamber 18, e.g., proximate adistal end of chamber 18. Sheath 42 may comprise a flexible polymericmaterial and include a perforate line 44 (e.g., a series of small holesor thinned portions extending through at least a portion of thethickness of sheath 42) so as to facilitate tearing along perforate line44. A proximal end of sheath 42 includes one or more flanges, grips, ortabs 46 to allow for a secure grip on sheath 42 by the medicalprofessional. Optionally, a distal end of sheath 42 includes one or moreretractors 48, described in further detail below. In such anarrangement, delivery of implant 12 is performed via proximal retractionof sheath 42 or chamber 18 (or chamber 22) (e.g., in the direction ofarrow P), e.g., relative to the plunger head of plunger rod 38 discussedabove. To do so, a medical professional may pull on tabs 46 of sheath 42which tears (e.g., peels away) sheath 42 along perforate line 44 therebyslowly exposing a distal portion of implant 12, allowing the naturalexpansion of exposed implant 12 (e.g., the exposed gel-filled structure)to pull the remaining portion of implant 12 out of chamber 18 and intothe breast pocket (or other site of implantation for the type ofimplant) of the patient.

As shown in FIG. 6 , retractor(s) 48 extend radially outward (e.g.,relative to a longitudinal axis C of chamber 18, FIG. 3 ), and may havethe shape of a flange or cone. In some examples, retractor(s) may have ashield-like configuration. In use, retractor(s) 48 may be placed withinthe incision during an implantation procedure and may help to minimizedamage to the skin and/or other tissues of the patient, and/or may helpto stabilize the introducer device 10 during the implantation procedure.As shown, retractor(s) 48 are integrated with sheath 42. However, thedisclosure is not so limited. In some arrangements, retractor(s) 48 maybe separate components used independently of any other device, or, maybe coupled to any one or more of chamber 18 (or chamber 22) or shaft 16.In any arrangement, however, retractor(s) 48 may help to minimize therisk of introducing bacteria (or other micro-organisms) into theincision site. Additionally or alternatively, the retractor(s) 48 mayserve to minimize the exposure of implant 12 to other surgicalinstruments (e.g., scalpels, needles, forceps, etc.) to reduce the riskof damage to implant 12 during the implantation procedure. For example,retractor(s) 48 may minimize the risk of rupturing shell 14 of implant12 during implantation.

Retractor(s) 48 may be flexible or semi-rigid (e.g., constructed of amaterial providing the appropriate flexibility, yet also providingstability upon insertion in the incision site) and may be adaptable forplacement into incisions of various dimensions and locations (e.g., asillustrated in FIG. 1 ). In some aspects, sheath 42 has a generallytubular shape, e.g., an extruded tubular structure. Additionally, sheath42 and/or retractors 48 may comprise a polymer or copolymer that hassufficient rigidity to support implantation of implant 12 whileemploying a thin-wall construction that can be collapsed, folded, brokenor peeled-away without displacing implant 12. Exemplary materialssuitable for such sheaths and retractors include, but are not limitedto, nylon, polyethylene, polyurethanes, polyamides, fluoropolymers suchas, e.g., polytetrafluoroethylene (PTFE), polyolefins,polyetheretherketones (PEEK), and flexible acrylics, and combinationsthereof. The linear extrusion process of materials such aspolytetrafluoroethylene may incorporate perforate line 44 (e.g., anintrinsic line of separation), e.g., due to the process or molecularorientation of the extruded material.

In some aspects of the present disclosure, retractor(s) 48 or sheath 42may comprise a reinforced ring (not shown) that allows unrestrictedmovement of surgical tools used to create the tissue pocket (e.g.,breast pocket) and to introduce implant 12. The reinforced ring may beflexible or rigid, and may include a slick or lubricious surface toreduce friction, e.g., to facilitate the introduction of implant 12 witha lower risk of abrasion or friction against implant 12. In combinationwith implants having biocompatible surface characteristics as discussedabove (including, e.g., Motiva Implant Matrix® SilkSurface™ andVelvetSurface™ implants), retractor(s) 48 may allow implant 12 to beintroduced into the tissue pocket while minimizing trauma to thesurrounding tissue. Retractors 48 according to the present disclosuremay be used for any location of the incision, such as incisions forinframammary, peri-areolar or trans-axillary implantation procedures(see, e.g., FIG. 1 ).

FIGS. 7A and 7B illustrate another exemplary introducer device 50according to aspects of the present disclosure, in which chamber 18 (orchamber 22) is not secured to introducer device 50. In such a device,chamber 18 or 22 may be omitted completely, or alternatively, may beused to compress, elongate, or otherwise transition or maintain implant12 in the insertion configuration (see, e.g., FIG. 2 ). Once implant 12has been positioned in the insertion (e.g., reduced profile)configuration, chamber 18 or chamber 22 may be used to insert implant 12into a shaft 52 of introducer device 50 (e.g., prior to connection ofnozzle 110 via ring 106). Once received within shaft 52, chamber 18 or22 may be discarded or sterilized and reused. Shaft 52 may include anyof the features or dimensions of shaft 16 above.

Introducer device 50 may have a similar construction and manner of useas introducer device 10. As such, introducer device 50 includes a shaft52 extending from a handle 54 (e.g., a squeeze-type or compressionhandle) including a first arm 56 rotatable about a pivot 58 (e.g., adowel rod) (see FIG. 7B) and movable toward a second arm 60. First arm56 is biased away from second arm 60 via a bracket 62 and torsion spring64 supported by a dowel rod 65, as shown in FIG. 7B. To compress handle50, a medical professional may first overcome the force imparted byspring 64. Handle 54 includes first (e.g., left) half portion 54A andsecond (e.g., right) half portion 54B positioned on opposite sides of aplane extending along longitudinal axis L. Housed within first halfportion 54A and second half portion 54B are a pair of lock plates 66 onopposite sides of a plunger rod 68. Each lock plate 66 secures a shaftbase 70 to a respective one of first half portion 54A and second halfportion 54B via a plurality of fasteners (e.g., screws 72). First halfportion 54A and second half portion 54B are each coupled to a respectivecover 82 and 84, as shown in FIG. 7A and FIG. 7B.

Plunger rod 68 includes a proximal end coupled to (e.g., threadably,adhesively, etc.) a T-handle 86 which may be sized to enable grasping bya medical professional as needed and/or desired. A distal end of plungerrod 68 is coupled to a plunger head 88. Plunger head 88 includes a pairof circumferentially extending channels or grooves 90 and 92, withineach of which a respective one of a pair of o-rings 94 and 96 isreceived. O-rings 94 and 96 prevent fluid (e.g., lubrication,aspiration, and/or irrigation fluid from passing proximally of plungerhead 88. Additionally, proximal end of shaft 52 includes a portion 98releasably coupleable to a proximal lock or ring 100, e.g., via threadsor other complementary mating features of an internal surface of ring100. For example, portion 98 may include threads and the internalsurface of ring 100 may be correspondingly threaded. That is, each ofthreaded portion 98 and ring 100 may include a thread profile having amatching pitch and/or orientation. Upon connection of portion 98 andring 100, a gasket 102 is compressed between and/or about a periphery ofshaft base 70 so as to secure shaft base 70, and thereby handle 54, toshaft 52. A distal end of shaft 52 includes a portion 104 releasablycoupleable to a distal lock or ring 106, e.g., via complementary matingfeatures. For example, portion 104 may include threads and the internalsurface of ring 106 may be correspondingly threaded. That is, each ofportion 104 and ring 106 may include a thread profile having a matchingpitch and/or orientation. Upon connection of portion 104 and ring 106, agasket 108 is compressed between and/or about a periphery of a proximalend of a nozzle 110 so as to secure nozzle 110 to shaft 52.

Nozzle 110 may be formed from or otherwise include a pliable polymer(e.g., polyurethane, polyethylene, silicone, etc.), which may be rigidenough to dilate an incision site, but soft enough to avoid tearing ordamaging the site. An opening 112 at the distal end of nozzle 110 mayhave any suitable shape, such as, e.g., round, oval, half-oval (e.g.,having one side that is flat and another side that is rounded or oval),or angular in shape. The shape of nozzle 110 may be selected toaccommodate the shape of implant 12 to be introduced into a patient(e.g., a half-oval or angular shape to accommodate a non-round implant).Nozzle 110, as shown in FIGS. 7A and 7B, is tapered such that a distalend diameter is smaller than a proximal end diameter of nozzle 110.Additionally, the length of nozzle 110 may be varied, as needed ordesired. For example, the degree or angle of taper, diameter of thedistal opening, and length of nozzle 110 may be selected so as tocorrelate to, and to accommodate, differently sized implants. In use, amedical professionally may deliver implant 12 (not shown in FIGS. 7A and7B) loaded within shaft 52 via actuation of handle 54 to advance plungerhead 88 towards nozzle 110. As plunger head 88 is advanced distally,implant 12 is pushed through opening 112 and delivered into the breastpocket of a patient.

As noted above, implant 12 may be inserted through an umbilicus incision8 to minimize visible scarring. In such a procedure, incision 8 istypically made in the umbilicus to introduce a blunt dissectinginstrument to form a tunnel 120 (see FIGS. 8A and 8B), over which alarger cannula or tube is inserted and advanced to a tissue pocket 130where implant 12 is to be positioned. Forming tunnel 120 separatessubcutaneous tissue 122 (e.g., fat located under the skin 124) from therectus sheath 126 positioned anterior of the rectus abdominis muscle128.

A challenge associated with this approach is compressing implant 12sufficiently to be “pushed” through tunnel 120. Typically, the cannulaused to form tunnel 120 is too small in diameter to deliver currentimplant 12 designs, such that the cannula only serves to establish asubcutaneous tunnel. After formation of tunnel 120, implant 12 isadvanced through tunnel 120, which imparts many additional forces andstresses on implant 12, thus increasing the probability of damage toimplant 12, such as rupture of shell 14.

To improve patient safety and reduce the trauma to implant 12 andsubcutaneous tissues 122 of the patient associated with such procedures,an introducer system employing one or more of the features of theexamples above may be used. For example, introducer device 10 orintroducer device 50 may be used in conjunction with a tunneling sheath132 (see FIGS. 9A-9B and 10A-10C). Alternatively, any introducer deviceherein described may be used instead of introducer device 10. Introducerdevice 10 (or any other described introducer device) as well astunneling sheath 132 includes a length sufficient to reach the intendedarea (e.g., breast pocket 130) for implantation from umbilicus incision8 (see, e.g., FIG. 1 ).

For example, as shown in FIGS. 9A and 9B, tunneling sheath 132, having adimension or length sufficient to extend from incision 8 to breastpocket 130, and having an internal diameter sufficient to receivetherein shaft 16 of insertion device 10 and/or implant 12 in theinsertion configuration (e.g., reduced profile configuration) isadvanced through incision 8 to breast pocket 130. The diameter oftunneling sheath 132 may correlate to the size of an incision, and assuch, may be between about 1.0 cm and about 3.0 cm, e.g., between about1.5 cm and about 2.5 cm, e.g., about 1, 1.5, 2, 2.5, or 3 cm. To enhancethe stability and pushability of tunneling sheath 132, an inner trocar134 or cannula (having a smaller diameter) may be used (FIG. 9A). Thatis, inner trocar 134 may be inserted through a lumen of tunneling sheath132 and both may be simultaneously advanced through tunnel 120. A bluntdistal end 136 of inner trocar 134 may separate tissues to form tunnel120. Inner trocar 134 and tunneling sheath 132 form a coaxial system tofacilitate insertion and advancement of implant 12. Once the tunnelingsheath 132 is properly positioned, inner trocar 134 may be removed toallow for access to a lumen extending through tunneling sheath 132.Next, shaft 16 of insertion device 10 may be inserted into the channelof tunneling sheath 132 (FIG. 9B) so as to advance implant 12 throughtunneling sheath 132, and may be actuated as discussed above, to advanceimplant 12 into breast pocket 130. Such an insertion approach mayminimize the entry wound/incision and length of travel from the entryincision to breast pocket 130. Smaller incisions and tunnel 120 lengthsmay reduce trauma and result in faster healing rates and fewercomplications.

In some aspects, blunt distal end 136 of trocar 134 may include featuresfor attachment of a suture or thread. For example, distal end 136 mayinclude an eyelet 138, as shown in FIG. 10A. A line 140 such as amonofilament thread having a small diameter is secured to eyelet 138 andpulled through tunneling sheath 132 with trocar 134 (FIG. 10A). A smallincision or opening through or proximate to breast pocket 130 enables amedical professional to grasp and thread line 140 from the breast pocket130, through the opening, and exterior of the patient's body forhandling, e.g., pulling, by the medical professional. Exemplarymaterials for line 140 include, but are not limited to, polymers, fibers(e.g., similar to suture material or a fishing line), and metals ormetal alloys, such as metallic wire. Following formation of tunnel 120and threading at least a portion of line 140 through the opening in thebreast pocket 130, trocar 134 may be withdrawn through the lumen oftunneling sheath 132, thereby pulling a portion of line 140 therewith.As such, at least a portion of line 140 is left in tunnel 120 (FIG. 10B)established by the trocar 134 once trocar 134 is removed. Line 140 thenmay detached, e.g., untied, from eyelet 138 and later secured to aseparate bag, sack, or chamber 22 (or optionally chamber 18) in whichimplant 12 is housed in the insertion configuration. Once coupled, themedical professional may gently pull implant 12 (within the separatebag, sack, or chamber, e.g., chamber 22 or 18) through tunnel 120 fromthe opposing end (FIG. 10C). Additionally or alternatively, upon removalof trocar 134, an elongated plunger (not shown) may be used to advance(e.g., push) implant 12 through the lumen of tunneling sheath 132 untilimplant 12 exits the distal end of tunneling sheath 132 and expandstowards the deployed configuration within the breast pocket 130.

As mentioned above, introducer devices described herein (e.g.,introducer devices 10, 50) may be used for implantation of implant 12with visco-elastic and/or highly elastic properties, e.g., comprising anelastic shell and visco-elastic silicone gel. Such elastic properties ofimplant 12 enable implant 12 to be stretched or elongated for loadinginto a chamber (e.g., chamber 18, chamber 22, etc.) in a reduced profilefor implantation in a minimally-invasive manner with less trauma to thepatient. For example, various properties of implant 12 may allow foruniform radial compression of implant 12, which may provide an abilityto safely compress implant 12 for advancement into a smaller incision(e.g., an incision of less than about 3.0 cm) than is conventionallyused in the implantation procedure.

As noted above, a plunger (e.g., plunger rod 38 or 68 having a plungerhead 88, etc.) may be used for pushing or urging the compressed implant12 from the introducer device through a tapered funnel or nozzle (e.g.,nozzle 110, FIGS. 7A-7B) and into the incision site. In some examples,and depending on the type and features of the implant, for example, thispushing mechanism may impose a significant load on a proximal portion ofimplant 12, e.g., creating excessive pressure between implant 12 and theintroducer device (e.g., an inner wall of shaft 16 or shaft 52). In somecases, the pressure may lead to a rupture of shell 14 of implant 12,and/or may cut, sever, or otherwise deform implant 12 upon expulsionfrom the introducer device (e.g., introducer device 10, introducerdevice 50, etc.).

In some arrangements, a fluid barrier between the plunger head (e.g.,plunger head of plunger rod 38, plunger head 88 of plunger rod 68, etc.)and implant 12 may be used to at least partially alleviate pressurebetween implant 12 and the introducer device. Depending on the type ofimplant and/or introducer device, however, mechanical pressure may causewater or other fluid (e.g., saline solution) to flow aroundcircumferential edges and/or creases or fold of implant 12 and/or leakout of a distal portion of the selected introducer device. Such leakingwater or fluid, however, may impart additional pressure to implant 12,such that implant 12 may be further compressed thus further elongatingimplant 12 and/or reducing a diameter of implant 12.

In some aspects of the present disclosure, an introducer device may usecompressed gas (e.g., CO₂, air, or other suitable inert gas) to advanceimplant 12 from inside a shaft and/or a chamber, and through a taperednozzle located at a distal end of the introducer device. For example,the gas may provide a buffer between implant 12 and the walls of theintroducer device shaft similar to water. In a manner similar to theleaking water flow example discussed above, compressed gas may leakaround the circumference of implant 12 as it is urged out of the distalend of the device. However, the pressure from the compressed gas mayhelp further radially-compress the implant as the continuous airpressure pushes implant 12 from the proximal end of the introducerdevice toward the nozzle at the distal end of the device chamber.

In some aspects of the present disclosure, a compressed gas source 142may be used to pull an implant into a shaft (similar to shaft 16, shaft52, etc.) of the introducer device. The implant may be lubricated, e.g.,comprising a lubricant on the surface of the implant. For example, asshown in FIG. 11 , ring 100 of introducer device 150 may be unscrewed orotherwise uncoupled from handle 154 and fluidly coupled to compressedgas source 142 (e.g., a negative pressure source referred to as aventuri vacuum) via any appropriate conduit 144. Additionally, nozzle158 may be uncoupled from shaft 152 by unscrewing or otherwiseuncoupling ring 160 from shaft 152. Shaft 152 may include any of thefeatures or dimensions of shaft 16 and/or 52 above. Once so arranged, adistal end of shaft 152 (e.g., an end closer to ring 160) may bepositioned near, adjacent to, or in contact with implant 12 (e.g.,having a lubricated shell 14 as discussed above). Next, compressed gassource 142 may be activated in any appropriate manner so as to pull,suck, or otherwise draw implant 12 into shaft 152 through the distal endof shaft 152. Once received within shaft 152, ring 100 may be unscrewedor otherwise uncoupled from conduit 144 and compressed gas source 142,and then may be coupled to handle 154, as discussed above. Additionally,nozzle 158 may be coupled to the distal end of shaft 152 via ring 160.While FIGS. 11 and 12 refer to components of introducer device 150, thedisclosure is not so limited. Rather, a proximal end of the shaft 16 ofintroducer device 10 may likewise be coupled to compressed gas source142 to draw implant 12 through a distal end of shaft 16 (e.g., followingremoval of compression ring 26 and chamber 18 or chamber 22).

Alternatively, following drawing implant 12 into shaft 152, compressedgas source 142 may remain coupled to shaft 152 and switched or toggledin a reverse direction so as to produce a positive pressure source toforce or push implant 12 so as to expel implant 12 from shaft 152 andinto an appropriate implantation location (e.g., breast pocket 130) of apatient. In order to facilitate switching between negative and positivepressure types (e.g., a direction of flow of compressed gas), compressedgas source 142 and/or introducer device 150 may utilize a valvemechanism (not shown) that allows the user to switch between these twofunctions. In other words, compressed gas source 142 may be used to bothload and expel implant 12 from introducer device 150. Thus, the devicemay provide a self-contained system equipped to provide a vacuum orexpulsion pressure, as opposed to connecting different wall attachmentsfor vacuum or compressed air/gas. In at least one example in whichcompressed gas source 142 is used to expel implant 12, handle 154 neednot be reattached to shaft 152 via ring 100.

FIG. 13 illustrates various features of exemplary introducer device 150according to aspects of the present disclosure. Introducer device 150may be a self-contained introducer device including a shaft 152 having ahandle 154 coupled to a first (e.g., proximal end) of shaft via a ring156 and a tapered nozzle 158 coupled to a distal end of shaft 152 via aring 160. As shown in FIG. 13 , a disposable compressed gas cartridge162 (e.g., a compressed CO2 or air cartridge) is coupled to handle 154via any suitable connector or adaptor, and may be replaced as needed toreplenish the source of compressed gas. Handle 154 includes a toggle orswitch 164 actuatable to alternate between vacuum and expulsion pressuregenerated with the compressed gas cartridge 162. The mechanism mayinclude a toggle switch for changing between a vacuum mode and apressure mode. Additionally, handle 154 includes a trigger 166 or othersuitable actuator for generating the vacuum or pressure.

Nozzle 158 may be disposable and may comprise a biocompatible material,such as a pliable polymer (e.g., a polyurethane, polyethylene, silicone,etc.) that is rigid enough to dilate an incision site, but soft enoughto avoid tearing or damaging the incision site. Similar to nozzle 110, adistal opening 168 of nozzle 158 may have any suitable shape, such as,e.g., round, oval, slitted-duckbill, half-oval (e.g., having one sidethat is flat and another side that is rounded or oval), or angular inshape to accommodate implant 12 to be implanted. The dimensions ofnozzle 158 (e.g., length and distal diameter) may be selected inaccordance with the dimensions and/or requirements of implant 12.

Switch 164 may include a mechanism by which the medical professional mayselect a negative pressure (e.g., the venturi vacuum) to pull implant 12into shaft 152 of introducer device 150 (e.g., prior to attachment ofnozzle 158), and then actuate switch 164 to reverse the valve mechanismto provide compressed gas for expelling implant 12. Other such vacuumeffects can be generated by known displacement or rotary vacuummechanisms. It is also contemplated that trigger 166 and/or switch 164may be electrical or digital, and operate by sending signals to oneanother and/or to the valve mechanism to move between the negative(e.g., vacuum) and positive pressure configurations, and to actuate thedispensing of compressed gas from cartridge 162.

FIGS. 14 and 15 are a schematic views of a proximal portion of anintroducer device during the vacuum configuration or mode that may beused to load an implant into the delivery chamber of the introducerdevice. As shown, when switch 164 (FIG. 13 ) is set to the vacuumconfiguration, a user may pull trigger 166 (FIG. 13 ) to causecompressed gas to move from cartridge 162, through an opening 170 in acircumferential side surface of the device. Optionally, opening 170 mayinclude an inlet conduit as shown in FIG. 15 . Once the gas movesthrough opening 170, the valve mechanism urges gas proximally throughand out of the device via an exhaust port 172 positioned at the proximalend of the device. Operating the device in this manner may have theeffect of a vacuum on portions of the introducer device 150 that aredistal to opening 170 (e.g., shaft 152 within which implant 12 may beloaded). By toggling switch 164 to the pressure/dispensing configurationor mode, the valve mechanism may be altered such that once thecompressed gas moves from cartridge 162 and through opening 170, the gasmay be directed distally through shaft 152 to urge implant 12 distallyout of introducer device 150. In some aspects, introducer device 150 mayfurther include a pressure relief valve to relieve excess pressurewithin shaft 152.

FIGS. 16A and 16B illustrate a further exemplary introducer device 180according to aspects of the present disclosure. Introducer device 180may have a similar construction and manner of use as introducer device150 (e.g., FIG. 13 ). For example, similar to introducer device 150,introducer device 180 includes a compressed gas cartridge 186. Handle184 includes first (e.g., left) half portion 184A and second (e.g.,right) half portion 184B positioned on opposite sides of a planeextending along longitudinal axis L and coupled together via a pluralityof connectors (e.g., screws 190). In addition to compressed gascartridge 186, housed within first half portion 184A and second halfportion 184B is a pump 192. Pump 192 may include any appropriate pumpingmechanism such a reciprocal or rotary pump. As shown in FIG. 16B, eachof compressed gas cartridge 186 and pump 192 is fluidly coupled to avalve mechanism 194 via one or more conduits 196 (e.g., conduits196A-196D).

For example, conduits 196A and 196 D may control pressure, and conduits196B and 196C may control suction, e.g., through a venture vacuum.Additionally, each end of each conduit 196A-196D may include a fitting198 to fluidly couple and secure a respective one end of each conduit196A-196D to one or more of compressed gas cartridge 186, pump 192,valve mechanism 194, and shaft 182, as shown in FIG. 16B. Shaft 182 mayinclude any of the features or dimensions of shaft 16, 52, and/or 152above.

Handle 184 includes a toggle or switch 200 (also referred to herein as amode selector) actuatable to alternate between vacuum and expulsionpressure (e.g., a vacuum mode and pressure mode) generated with thecompressed gas cartridge 186. The switch 200 may include a toggle switchfor adjusting valve mechanism 194 between a vacuum mode and a pressuremode. A lower surface of switch 200 may define a cam surface thatcontacts valve 194 to switch between a suction mode and a pressure mode,e.g., via conduits 196B and 196C, and conduits 196A and 196D. As such,in a first orientation of switch 200 relative to handle 184, valvemechanism 194 is arranged to generate vacuum pressure in shaft 182. In asecond orientation of switch 200 relative to handle 184, valve mechanism194 is arranged to positive expulsion pressure in shaft 182.

Additionally, handle 184 includes a trigger 210 for generating vacuum orpositive pressure in shaft 182. As shown, for example, trigger 210 mayinclude an L-shaped bracket or arm having one end 212 pivotably coupledto handle 184 via shaft or dowel rod/pin 214. Additionally, trigger 210is coupled to valve mechanism 194. Further, as shown in FIG. 16B, handle184 includes locking levers 197 that secure the proximal end of shaft182 to handle 184. Each locking lever 197 pivots about a pin 199extending through an aperture of locking lever 197 and is coupled to aspring 195. By pivoting locking levers 197 radially outward about pins199, the ends of locking levers 197 may release from a circumferentialgroove at the proximal end of shaft 182 to release shaft from handle184. Thus, handle 184 may be detached from shaft 182 following aprocedure and be reused, following sterilization of handle 184, e.g.,via autoclave.

Further, handle 184 includes a core seal 240 retained between first halfportion 184A and second half portion 184B. Core seal 240 may compriseany appropriate material such as, for example, a polymer, rubber, or thelike. As shown in FIG. 16B, one or more of fittings 198 may be coupledto a lumen 242 extending through core seal 240 so as to deliver negativeand/or positive pressure to shaft 182. A distal portion of core seal 240is at least partially received within a lumen of shaft 182 while aremainder of core seal 240 is received within handle 184. An o-ring 244is positioned about a circumference of core seal 240, such that, uponcoupling of core seal 240 and handle 184, o-ring 244 is received withinan internal channel of handle 184 and prevents fluid (e.g., gas) fromleaking proximally of o-ring 244. A second o-ring 246 is positionedabout a circumference of core seal 240 and distally of o-ring 244. Uponcoupling of core seal 240 and shaft 182, o-ring 246 is received withinthe lumen of shaft 182 and prevents fluid (e.g., gas) from leakingproximally of o-ring 246. Beyond prevention of proximal egress of gas orfluid, o-rings 244 and 246 may facilitate securing shaft 182 to handle184. Additionally, a distal end of shaft 182 is releasably coupleable(e.g., via an interference fit, threaded coupling, etc.) to a proximal aproximal end of a nozzle 248 so as to secure nozzle 248 to shaft 282.

Similar to nozzle 110, described above, nozzle 248 may be formed from orotherwise include a pliable polymer (e.g., polyurethane, polyethylene,silicone, etc.), which may be rigid enough to dilate an incision site,but soft enough to avoid tearing or damaging the site. An opening 250 atthe distal end of nozzle 248 may have any suitable shape, such as, e.g.,round, oval, half-oval (e.g., having one side that is flat and anotherside that is rounded or oval), or angular in shape. The shape of nozzle248 may be selected to accommodate the shape of implant 12 to beintroduced into a patient (e.g., a half-oval or angular shape toaccommodate a non-round implant). Nozzle 248, as shown in FIGS. 16A and16B, is tapered such that a distal end diameter is smaller than aproximal end diameter of nozzle 248. Additionally, the length of nozzle248 may be varied, as needed or desired. For example, the degree orangle of taper, diameter of the distal opening 250, and length of nozzle248 may be selected so as to correlate to, and to accommodate,differently sized implants 12. For example, a tapered nozzle (e.g.,nozzle 110, 158, 248, or 298 (described below)) may facilitateimplantation of implant 12 in a desired orientation or “right side up”manner. The diameter of such a nozzle may vary to accommodate varyingsized implants and correlate with a size or location of an incisionthrough which the implant is to be delivered. In at least one example,the nozzle may have an angled aperture, e.g., providing a larger openingfor implant to exit.

In use, a medical professional may remove (if not already done) nozzle248 from the distal end of shaft 182 and toggle switch 200 to the vacuummode. Then, the distal end of shaft 182 may be positioned near, adjacentto, or in contact with implant 12 (e.g., having a lubricated shell 14 asdiscussed above). Next, compressed gas source 186 may be activated viatrigger 210 as to pull, suck, or otherwise draw implant 12 into shaft182 through the distal end of shaft 182. Once implant 12 is housedwithin shaft 182, switch 200 may be toggled to the pressure mode (e.g.,expulsion mode) and nozzle 248 may be coupled to the distal end of shaft182, as noted above. Next, nozzle 248 may be positioned within, through,or near the incision site and compressed gas source 186 may be activatedvia trigger 210 as to push, force, or otherwise expel implant 12 fromshaft 182, through nozzle 248, and into the patient (e.g., into breastpocket 130).

Compressed gas sources 162, 186 may have any appropriate volume anddimensions so as to contain and connect compressed gas to a respectiveintroducer device (e.g., introducer device 150, introducer device 180).For example, either or both of sources 162 and 186 may include a totallength of about 88.4 mm (approximately 3.5 inches), and a total width(e.g., diameter) of about 22 mm (approximately 0.875 inches). A neck orconnection between source 162, 186 and a remainder of introducer device150, 180, respectively may have a length of about 9 mm (approximately0.375 inches) and a width (e.g., diameter) of approximately 9 mm(approximately 0.375 inches). These dimensions are exemplary only andmay vary depending on other dimensions of the introducer device and/orvolume of compressed gas desired or required. Additionally, in someaspects, introducer device 180 may further include a pressure reliefvalve to relief excess pressure within shaft 182.

FIGS. 17A and 17B illustrate a further exemplary introducer device 270according to aspects of the present disclosure. Introducer device 270may have a similar construction and manner of use as introducer device180 (e.g., FIGS. 16 and 16B), except compressed gas source 186 and pump192 have been replaced with tubing assembly 280, coupleable to a sourceof compressed gas, such as facility gas supplies (e.g., hospital ormedical center building-supplied gas sources via utility hookups). Insome examples, introducer device 270 may be single-use or disposable.

For example, tubing assembly 280 includes a suction line 282 and apositive pressure line 284. Each of suction line 282 and pressure line284 includes a fitting 286 on a proximal end thereof for connection tothe facility gas supplies (not shown) and a fitting 288 (e.g., lueradapter) for connection to a corresponding connection line of theintroducer device 270. For example, fitting 288 of suction line 282 iscoupled to a first end of suction connection 290 while fitting 288 ofpressure line 284 is coupled to a first end of pressure connection 292.Additionally, a second end of suction connection 290 is coupled to afitting 294 of a core seal 298 while a second end of pressure connection292 is coupled to a fitting 296 of core seal 298. As shown, core seal298, in turn, is received within handle 274, e.g., between shaft 272 andhandle 274. Shaft 274 may include any of the features or dimensions ofshaft 16, 52, 152, and/or 182 above. As shown, handle 274 includes first(e.g., left) half portion 274 A and second (e.g., right) half portion274B coupled together via any appropriate manner such as, e.g., viascrews 276. Additionally, a distal end of shaft 272 is releasablycoupleable (e.g., via an interference fit, threaded coupling, pins 300,etc.) to a proximal end of a nozzle 298 so as to secure nozzle 298 toshaft 272. Nozzle 298 may be similar in shape and construction as nozzle248, described above.

Further, handle 274 includes two actuators to control suction andvacuum. For example, handle 274 may include a first actuator, trigger304 (e.g., controlled by an index finger of the user) for generating oneof vacuum or positive pressure in shaft 272, and a second actuator,e.g., actuator 307 (e.g., controlled by a thumb of the user) forgenerating the other of vacuum or positive pressure. Actuator 307 mayextend through the handle and define a portion of a valve. As shown,trigger 304 is rotatably coupled to handle 274 via bearing 306, whichcontrols valve 305, e.g., trumpet valve 305. In at least one example, Insome aspects, introducer device 270 may further include a pressurerelief valve to relief excess pressure within shaft 272.

In at least one example, the trigger 304 controls pressure and thesecond actuator 307 controls suction. In some examples, both actuatorsmay be pressed simultaneously to apply both pressure and suction. Forexample, actuator 307 may fluidly couple suction line 282 with shaft272, and trigger 304 may fluidly coupled pressure line 284 with shaft272. In such an arrangement, each of the suction and pressure may beapplied to shaft 272 simultaneously, if so desired. For example, toreduce the degree of suction applied via actuation of actuator 307, amedical professional may press trigger 304 to fluidly couple pressureline 284 with shaft 272.

In use, a medical professional may remove (if not already done) nozzle298 from the distal end of shaft 272 and fluidly couple suction line 282with shaft 272. Then, the distal end of shaft 272 may be positionednear, adjacent to, or in contact with implant 12 (e.g., having alubricated shell 14 as discussed above). Next, trigger 210 may beactuated so as to pull, suck, or otherwise draw implant 12 into shaft272 through the distal end of shaft 272. Once implant 12 is housedwithin shaft 272, pressure line 284 may be fluidly coupled with shaft272. Next, nozzle 298 may be coupled to the distal end of shaft 272, asnoted above, and nozzle 298 may be positioned within, through, or nearthe incision site. Trigger 210 then may be actuated so as to push,force, or otherwise expel implant 12 from shaft 272, through nozzle 298,and into the patient (e.g., into breast pocket 130).

In some arrangements, the introducer devices described herein (e.g.,introducer devices 150, 180, 270, etc.) may adapt to a sterile packagingsystem to provide a “touchless” implantation procedure. That is, thephysician, nurse, or other medical professional or user need notdirectly handle implant 12 when loading the implant 12 into theintroducer device (e.g., introducer devices 150, 180, 270, etc.) or atother times during implantation.

For example, as shown in FIGS. 18 and 19 , a separate sterile package320 may be sized and/or shaped so as to contain implant 12 therein. Asillustrated, package 320 may have the shape of a hemisphere with adiameter suitable for enclosing a specified sized and volume of implant12 (e.g., a breast implant). In some examples, a pull-tab opening 322may be integrated into either side of the sterile package 320. Theopposing side may be covered by a Tyvek material used in packagingsterile medical devices or other suitable material for sterilepackaging. The Tyvek lid or other portion of the package may alsoinclude a separate injection port (not shown) that may furtheraccommodate injection of sterile saline and/or lubricant.

As shown in FIG. 20 , for example, package 320 may be used inconjunction with introducer device 150. Alternatively, package 320 maybe used in conjunction with any introducer device described herein. Insome examples, package 320 may include features complementary tofeatures of a nozzle (e.g., nozzle 110, nozzle 158, nozzle 248, nozzle298, etc.) or a distal end of a shaft (e.g., shaft 16, shaft 52, shaft152, shaft 182, shaft 272, etc.) to allow the introducer device toconnect to package 320. For example, the distal end of the shaft 152 ofintroducer device may be threaded (or have other mating features) toallow the connection of the distal end of shaft 152 to package 320 viacomplementary threads (or other complementary mating features) ofpackage 320. In some examples, the introducer device may includecounter-threads or connection tabs located within the shaft 152. Forexample, threads may be thermoformed into the outer surface of package320 that contains implant 12.

In other examples, package may include a reduced diameter opening toreceive shaft 152. Optionally, package 320 may include an o-ring (asillustrated in FIG. 20 ) to provide for a better seal between shaft 152and package 320.

Package 320 may be designed in such a way that the user can use apull-tab 322 to open the sterile package (similar to opening a sealedcan), providing access to the enclosed implant 12. Pull-tab may belocated on the curved portion of package 320, as shown in FIGS. 18-20 ,or may be located on the opposite, substantially planar, portion ofpackage 320. For example, in some examples, pull tab may be removed fromthe planar portion of package 320 and the implant drawn into shaft 152.

While package 320 is opened, and prior to the connection of package 320to the shaft 152, the user can inject sterile saline and/or lubricantinto package 320 to aid in the movement of implant 12 into shaft 152.Once the connection between package 320 and shaft 152 is secured, thevacuum mode of the system may be used to then pull the lubricated,sterile implant 12 into shaft 152, to prepare implant 12 for injectioninto the incision site. Mating features or mechanisms other than threadsmay be used to connect the shaft 152 to sterile package 320. Thisloading system may help avoid any physical contact or minimize physicalcontact of implant 12 with the user and/or the surrounding environment,thereby reducing or eliminating the risks of puncture or introduction ofparticulate debris to the surface of implant 12.

Following experimentation, appropriate expulsion pressures to expelimplant 12 from an introducer device may correlate to i) the volume/sizeof implant 12, ii) the incision location and size, and iii) the nozzlediameter of the introducer device that is inserted within the incision.A chart may be provided to the end-user that defines these correlationsfor optimal device placement. The chart may be developed by bench andpre-clinical assessments, for example.

By way of example only, assuming implant 12 makes a perfect seal againstan inner surface of the shaft (e.g., shaft 16, 52, 152, 182, 272, etc.),the volume of gas/fluid sufficient to expel implant 12 may be equal tothe implant volume (up to 925 cc (cubic centimeters)). An alternativeway to calculate required air pressure to expel implant 12 is todetermine the pressure needed to expel the entire volume of the shaft(e.g., shaft 16, 52, 152, 182, 272, etc.) (in one example, thedimensions of the shaft are approximately 2 inches (diameter) by 12inches (length)), or about 625 cc. The same pressure may be used tovacuum load the implant into the chamber of the introducer device.

For some exemplary implantation procedures, 1000 cc or about 60 ci(cubic inches) is sufficient to propel an implant having a volume of upto about 925 cc. Thus, if the vacuum pump is 100% efficient, 60 ci ofCO₂ (or other suitable gas) may be used to load implant into the shaftof the introducer device, and to subsequently propel implant from theshaft. Using Boyle's Law (P₁V₁P₂V₂), along with the followingassumptions, the chart below provides for the range of potential volumesof various compressed gas sources (e.g., source 162, source 186) thatwould supply sufficient gas pressure for loading and expulsion of asilicone gel implant with a range of volumes that require 30 psi:

-   -   4 A constant temperature at 70° F.    -   Gas supply minimum fill pressure of 800 psi    -   25 psi for both loading and expulsion of implant 12    -   12 g (3 inch) gas supply 18 cc (1 ci)

TABLE 1 Size Volume @ STP (14.7 psi) Volume @ 30 psi * 12 g  6 L 3 L(183 ci) 16 g  8 L 4 L (244 ci) 20 g 10 L 5 L (305 ci) 33 g 17 L 8 L(494 ci) 45 g 23 L 11 L (671 ci) 

In addition, it is known that one mole of an ideal gas occupies a volumeof 22.4 liters at STP (Standard Temperature and Pressure, 0° C. (273.15°K) and one atmosphere pressure (14.7 psi)). Using the followingparameters, a 16 g gas supply may provide sufficient volumes andpressures for an average size breast implant procedure.

The ideal gas law PV=nRT may be used to calculate the volume of gas atatmospheric pressure for a given amount of gas, wherein:

-   -   P is the pressure of the gas (atm)    -   V is the volume of the gas (L)    -   T is the absolute temperature of the gas 273. 5° K    -   R has the value: 0.08206 L atm/(mol·K).    -   n is the number of moles of the gas (mass/molecular weight)

Accordingly, and by way of example only, for a gas supply containing 16g of CO₂:

-   -   1 mole of CO₂ is 44 grams (i.e., molecular weight=44 g/mol)    -   n=(16 g)/(44 g/mol)=0.36 moles CO₂    -   P=1 atm    -   PV=nRT    -   V=about 8 liters (0.28 cubic feet) of CO₂ at 1 atm    -   To calculate the volume of gas for other pressures @ constant        temperature: P₁V₁=P₂V₂.

Therefore, this system may provide for the use of disposable gas (e.g.,CO₂, air, or air/CO2 mixtures) sources (e.g., 162, 186) in the range of12-33 g and volumes from 180 ci to 500 ci, providing an average pressureof 30 psi for both the vacuum and expulsion processes during animplantation procedure.

The introducer devices described herein may be used to standardizeand/or facilitate procedures for implantation of a breast implant orother such implant device. In some examples, the introducer device maybe configured for one-handed advancement of the implant. Additionally,any one or more of the shafts (e.g., 16, 52, 152, 182, 272), chambers(e.g., 18, 22), tunneling sheath 132 or other such device may beconstructed of a low-friction material, such as polytetrafluoroethylene(Teflon®), and/or coated with a highly lubricious (e.g., hydrophilic)material to reduce the coefficient of friction between the introducerdevice and implant 12. In some aspects, a combination of features of theimplant and the introducer system may help to optimize aminimally-invasive procedure, e.g., to improve patient well-being. Forexample, a breast implant characterized by surface texturing, highelongation, high shell strength, and super visco-elastic and consistentsilicone filling gel may be implanted with an introducer device asdescribed above in a minimally-invasive insertion method to minimizescarring of the incision site, reduce the risk of damaging the implantduring placement, and/or to accelerate and optimize healing of thesurgical wound.

While principles of the present disclosure are described herein withreference to illustrative aspects for particular applications, it shouldbe understood that the disclosure is not limited thereto. For example,as noted above, any of the disclosed introducer devices (e.g.,introducer device 150, 180, or 270) described above may further includea pressure relief valve to relief excess pressure within a respectiveshaft (e.g., shaft 152, 182, or 272). Those having ordinary skill in theart and access to the teachings provided herein will recognizeadditional modifications, applications, aspects, and substitution ofequivalents all fall within the scope of the aspects described herein.Accordingly, the present disclosure is not to be considered as limitedby the foregoing description.

We claim:
 1. A medical device, comprising: a shaft extending between aproximal end and a distal end, the shaft including a lumen therein; ahandle coupled to the proximal end of the shaft and including a modeselector, wherein the mode selector is adapted to transition between afirst mode and a second mode of the medical device: and a compressedfluid source; wherein, in the first mode, the compressed fluid source isfluidly coupled with the shaft so as to impart a negative pressure in atleast a portion of the lumen, and wherein in the second mode, thecompressed fluid source is fluidly coupled with the shaft so as toimpart a positive pressure in the at least a portion of the lumen.